RecruitingPhase 2NCT07263386

A Phase II, Multicenter, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Sintilimab Plus SOX Versus SOX Alone as Adjuvant Therapy for PD-L1-Positive, Stage pN3 Gastric Cancer


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

460 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study intends to enroll gastric cancer patients who are PD-L1 positive and pathologically confirmed as Stage N3. Enrolled patients will be randomly assigned to receive either standard adjuvant SOX regimen or SOX regimen combined with sintilimab. The objective of the study is to determine whether adding a PD-1 inhibitor to postoperative chemotherapy can improve the Disease-Free Survival (DFS) rate in patients with Stage N3 gastric cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding sintilimab (an immunotherapy drug that helps the immune system attack cancer) to standard chemotherapy after stomach cancer surgery can reduce the chance of the cancer coming back in patients with a specific high-risk cancer type. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with gastric (stomach) adenocarcinoma - Your cancer was completely removed by surgery with extensive lymph node removal (D2 or wider resection, R0 status) - Your cancer was at pathological stage N3 (extensive lymph node involvement) without distant spread - Your tumor tests positive for PD-L1 (a marker predicting immunotherapy benefit, CPS ≥1) - You did not receive chemotherapy before surgery **You may NOT be eligible if...** - You received neoadjuvant (pre-surgery) chemotherapy - Your surgery did not achieve clear margins - Your cancer has spread to distant organs - You have autoimmune conditions or cannot tolerate immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab

For patients with body weight \< 60 kg, the dose is 3 mg/kg, administered via intravenous infusion (i.v.gtt.) on Day 1; for patients with body weight ≥ 60 kg, a fixed dose of 200 mg is administered via intravenous infusion (i.v.gtt.) on Day 1. The treatment is repeated every 21 days.

DRUGSOX Chemotherapy

S-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT07263386


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